Description

+ Perform analytical testing on raw materials, in-process samples, finished products, stability samples, and complaint samples using compendial and internal methods in accordance with cGMP guidelines.

+ Operate and maintain laboratory instrumentation, ensuring all testing is executed consistently, accurately, and in compliance with established SOPs.

+ Document all work in laboratory notebooks, logs, or electronic systems and report any out-of-specification (OOS) results, equipment issues, or method discrepancies to leadership.

+ Support quality and compliance activities by participating in investigations, conducting peer review of data, and preparing timely and accurate QC reports.

+ Assist in drafting and revising SOPs and train junior analysts in areas of expertise as needed.

+ Maintain an inspection-ready laboratory environment by ensuring proper inventory of supplies, performing routine cleaning and housekeeping, ...